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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80307

38 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 12, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Avella of Deer Valley, Inc. Store 38

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

38 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 38

0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02

D-0928-2018
Recall number
D-0928-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
40 pumps

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 5/14/18 0749 525-66102, BUD 6/13/2018; 5/22/18 0837 495-66102, BUD 6/21/2018

Distribution pattern

Nationwide in the USA

drug · product 2 of 38

ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10

D-0929-2018
Recall number
D-0929-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
2,500 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 4/27/18 2002 60410P, 4/27/18 2030 60410P, BUD 6/26/2018

Distribution pattern

Nationwide in the USA

drug · product 3 of 38

ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61

D-0930-2018
Recall number
D-0930-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
5400 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 3/5/18 8055 80561S, 3/5/18 0514 80561S, 3/5/18 5259 80561S, 3/5/18 6131 80561S, 3/5/18 5641 80561S, BUD 7/3/2018; 5/10/18 1312 80561S, 5/10/18 1322 80561S, BUD 9/7/2018;

Distribution pattern

Nationwide in the USA

drug · product 4 of 38

EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.

D-0931-2018
Recall number
D-0931-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
420 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 5/4/18 0300 58-85525P, BUD 6/18/2018; 5/10/18 1435 262-85525P, 5/10/18 1127 558-85525P, BUD 6/24/2018; 5/11/18 1327 457-85525P, BUD 6/25/2018; 5/14/18 0302 295-85525P, BUD 6/28/2018; 5/17/18 0500 558-85525P, BUD 7/1/2018; 5/24/18 1005 57-85525P, 5/24/18 1328 295-85525P, BUD 7/7/2018; 5/25/18 0302 295-85525P, BUD 7/9/2018; 5/30/18 0936 262-85525P, BUD 7/14/2018; 5/31/18 0805 558-85525P, BUD 7/17/2018.

Distribution pattern

Nationwide in the USA

drug · product 5 of 38

EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.

D-0932-2018
Recall number
D-0932-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
700 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 4/30/18 0512 2-82325P, BUD 6/14/2018; 5/22/18 1238 82325P, BUD 7/6/2018.

Distribution pattern

Nationwide in the USA

drug · product 6 of 38

fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70

D-0933-2018
Recall number
D-0933-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
120 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 5/3/18 0317 142-21070S, BUD 8/1/2018; 5/10/18 0512 144-21070S, BUD 8/8/2018; 6/1/18 0305 142-21070S , BUD 8/30/2018; 6/4/18 0505 252-21070S, BUD 9/2/2018.

Distribution pattern

Nationwide in the USA

drug · product 7 of 38

HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25

D-0934-2018
Recall number
D-0934-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
240 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 138-20181505@92, BUD 8/23/2018; 138-20181605@78, BUD 8/24/2018

Distribution pattern

Nationwide in the USA

drug · product 8 of 38

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65

D-0935-2018
Recall number
D-0935-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
275 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 5/16/18 1207 22265S, BUD 8/14/2018.

Distribution pattern

Nationwide in the USA

drug · product 9 of 38

MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10

D-0936-2018
Recall number
D-0936-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
100 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 5/1/18 0501 548-90510P, BUD 7/30/2018.

Distribution pattern

Nationwide in the USA

drug · product 10 of 38

Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10

D-0937-2018
Recall number
D-0937-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
1860 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 5/7/18 7482 40110P, BUD 9/4/2018; 5/22/18 0804 40110P, BUD 9/19/2018; 5/3/18 1111 40110P, BUD 8/31/2018.

Distribution pattern

Nationwide in the USA

drug · product 11 of 38

MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10

D-0938-2018
Recall number
D-0938-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
1500 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/15/18 6413 24110P, BUD; 9/12/2018; 5/16/18 0744 24110P, BUD 9/13/2018.

Distribution pattern

Nationwide in the USA

drug · product 12 of 38

NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25

D-0939-2018
Recall number
D-0939-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
4,280 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #4/23/18 0101 81525P, 4/23/18 1020 81525P, BUD 6/22/2018;4/30/18 1123 81525P, 4/30/18 1311 81525P, BUD 6/29/2018; 5/1/18 3456 81525P, BUD 6/30/2018; 5/8/18 3213 81525P, BUD 7/7/2018.

Distribution pattern

Nationwide in the USA

drug · product 13 of 38

PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25

D-0940-2018
Recall number
D-0940-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
200 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 5/23/18 3812 89325P, BUD 8/6/2018.

Distribution pattern

Nationwide in the USA

drug · product 14 of 38

Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25

D-0941-2018
Recall number
D-0941-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
1,352 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot # 138-20181005@92, 138-20181005@91, 138-20181005@90, BUD 7/9/2018; 138-20181405@78, BUD 7/13/2018; 138-20181605@61, BUD 7/15/2018

Distribution pattern

Nationwide in the USA

drug · product 15 of 38

0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87

D-0942-2018
Recall number
D-0942-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
20 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot 5/14/18 0722 47-00287Y EXP 06/28/2018

Distribution pattern

Nationwide in the USA

drug · product 16 of 38

ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61

D-0943-2018
Recall number
D-0943-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
500 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 05/10/18 2011 89161S, BUD 9/7/2018

Distribution pattern

Nationwide in the USA

drug · product 17 of 38

fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87

D-0944-2018
Recall number
D-0944-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
15 cassettes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/14/18 0913 320-25087Y, BUD 6/28/2018.

Distribution pattern

Nationwide in the USA

drug · product 18 of 38

fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72

D-0945-2018
Recall number
D-0945-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
100 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/24/18 0502 149-21072S, BUD 8/22/2018.

Distribution pattern

Nationwide in the USA

drug · product 19 of 38

fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86

D-0946-2018
Recall number
D-0946-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
100 cassettes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/14/18 1012 172-27886Y, BUD 6/28/2018.

Distribution pattern

Nationwide in the USA

drug · product 20 of 38

HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25

D-0947-2018
Recall number
D-0947-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
900 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 138-20181105@65,138-20181105@64, 138-20181105@63, BUD 8/19/2018.

Distribution pattern

Nationwide in the USA

drug · product 21 of 38

HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25

D-0948-2018
Recall number
D-0948-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
40 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/1/18 0511 515-74725P, BUD 7/30/2018.

Distribution pattern

Nationwide in the USA

drug · product 22 of 38

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63

D-0949-2018
Recall number
D-0949-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
480 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 3/15/18 0954 22263M, BUD 6/13/2018.

Distribution pattern

Nationwide in the USA

drug · product 23 of 38

HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10

D-0950-2018
Recall number
D-0950-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
660 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 4/26/18 0520 22110P, BUD 8/9/2018; 5/14/18 1350 22110P, BUD 8/27/2018.

Distribution pattern

Nationwide in the USA

drug · product 24 of 38

MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10

D-0951-2018
Recall number
D-0951-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
25 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/15/18 0510 169-90610P, BUD 8/13/2018.

Distribution pattern

Nationwide in the USA

drug · product 25 of 38

MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10

D-0952-2018
Recall number
D-0952-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
175 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/2/18 0318 284-90710P, BUD 7/31/2018; 5/9/18 0502 423-90710P, BUD 8/7/2018; 5/18/18 0500 284-90710P, BUD 8/16/2018.

Distribution pattern

Nationwide in the USA

drug · product 26 of 38

MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25

D-0953-2018
Recall number
D-0953-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
130 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #:2/26/18 0301 24125P, BUD 6/26/2018.

Distribution pattern

Nationwide in the USA

drug · product 27 of 38

MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63

D-0954-2018
Recall number
D-0954-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
740 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #:2/26/18 2233 24363M, BUD 6/26/2018.

Distribution pattern

Nationwide in the USA

drug · product 28 of 38

Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63

D-0955-2018
Recall number
D-0955-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #:5/11/18 1050 28-40163M, BUD 7/25/2018.

Distribution pattern

Nationwide in the USA

drug · product 29 of 38

Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10

D-0956-2018
Recall number
D-0956-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
220 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #:5/21/18 0506 240-40810P, BUD 8/4/2018; 5/22/18 0501 86-40810P, BUD 8/5/2018; 5/25/18 0900 410-40810P, BUD 8/8/2018; 6/6/18 0836 86-40810P, BUD 8/20/2018.

Distribution pattern

Nationwide in the USA

drug · product 30 of 38

Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76

D-0957-2018
Recall number
D-0957-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
110 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #:5/14/18 2011 40176S, BUD 9/11/2018.

Distribution pattern

Nationwide in the USA

drug · product 31 of 38

NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25

D-0958-2018
Recall number
D-0958-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
520 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #:4/26/18 0515 83425P, BUD 6/25/2018; 4/24/18 1332 83425P, BUD 6/23/2018.

Distribution pattern

Nationwide in the USA

drug · product 32 of 38

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61

D-0959-2018
Recall number
D-0959-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
850 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/7/18 0301 2-80761S, BUD 6/21/2018; 5/9/18 0510 2-80761S, BUD 6/23/2018; 5/21/18 1807 80761S, BUD 7/15/2018.

Distribution pattern

Nationwide in the USA

drug · product 33 of 38

NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25

D-0960-2018
Recall number
D-0960-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
2280 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 4/30/18 2471 80725P, BUD 6/29/2018; 5/1/18 1240 80725P, BUD 6/30/2018; 5/8/18 1111 80725P BUD 7/7/2018.

Distribution pattern

Nationwide in the USA

drug · product 34 of 38

NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25

D-0961-2018
Recall number
D-0961-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
1290 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/14/18 1330 86025P, BUD 7/8/2018; 5/24/18 2314 86025P, BUD 7/18/2018. .

Distribution pattern

Nationwide in the USA

drug · product 35 of 38

PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25

D-0962-2018
Recall number
D-0962-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
120 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/22/18 1012 495-89425P, BUD 7/21/2018; 6/5/18 0302 495-89425P, BUD 8/4/2018. .

Distribution pattern

Nationwide in the USA

drug · product 36 of 38

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67

D-0963-2018
Recall number
D-0963-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
10500 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 3/5/18 6702 80567S, 3/5/18 2119 80567S, BUD 7/3/2018; 4/30/18 3701 80567S, BUD 8/28/2018; 5/10/18 3333 80567S, 5/10/18 2222 80567S, 5/10/18 1111 80567S, BUD 9/7/2018. .

Distribution pattern

Nationwide in the USA

drug · product 37 of 38

ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61

D-0964-2018
Recall number
D-0964-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
225 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 5/10/18 1451 89561S, BUD 9/7/2018 .

Distribution pattern

Nationwide in the USA

drug · product 38 of 38

PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25

D-0965-2018
Recall number
D-0965-2018
Initiated
June 12, 2018
Classification
Class II
Status
Terminated
Quantity
40 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

Code information

Lot #: 4/30/18 0732 558-85625P, BUD 6/29/2018 .

Distribution pattern

Nationwide in the USA